Application 016367

Type: NDA
Sponsor: ICU MEDICAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	INJECTABLE;INJECTION	50MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N016367-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016367-002	DEXTROSE 5% IN PLASTIC CONTAINER	50MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016367-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016367-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016367-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016367-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016367-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016367-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016367-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016367-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016367-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016367-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016367-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016367-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016367-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016367-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016367-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016367-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016367-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016367-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016367-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016367-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016367-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016367-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016367-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016367-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016367-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016367-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016367-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016367-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016367-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016367-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016367-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016367-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016367-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016367-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016367-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016367-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016367-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016367-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016367-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016367-002	AP	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose	DEXTROSE MONOHYDRATE	ICU Medical, Inc.	8b25b7e0-703e-4b43-a4eb-52863511602d	2025-11-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016367 application number: NDA016367 ndc (product): 0990-7923 ndc (product): 0990-7922

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7922	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0409-7923	Dextrose	dextrose monohydrate	Hospira, Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7922	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
0990-7923	Dextrose	dextrose monohydrate	ICU Medical Inc.	NDA	Current
51662-1211	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1211	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1211	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1214	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1214	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1214	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1306	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1306	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1306	DEXTROSE	DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1413	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1413	5% DEXTROSE	5% DEXTROSE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1493	DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1493	DEXTROSE MONOHYDRATE	DEXTROSE MONOHYDRATE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82526	SUPPL	2025-06-10
82518	SUPPL	2025-06-10
12991	SUPPL	2006-10-31
10888	SUPPL	2006-10-27
10887	SUPPL	2005-09-07
442	SUPPL	2005-09-07